ChiCTR2300074683 版本V1.0 版本创建时间2023/08/13 19:05:47 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300074683 

最近更新日期：

Date of Last Refreshed on：

 2023-08-13 19:05:21 

注册时间：

Date of Registration：

 2023-08-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Application of caregiver intervention program for Chinese dementia patients’ caregiver in Hong Kong

Public title：

Application of caregiver intervention program for Chinese dementia patients’ caregiver in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Psychology

Scientific title：

Application of caregiver intervention program for Chinese dementia patients’ caregiver in Hong Kong

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Wong Wing Sze Karen 

研究负责人：

Wong Wing Sze Karen 

Applicant：

Wong Wing Sze Karen 

Study leader：

Wong Wing Sze Karen 

申请注册联系人电话：

Applicant telephone：

 +852 6342 9102

研究负责人电话：

Study leader's
telephone：

+852 6342 9102

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 karenwongpsychologist@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 karenwongpsychologist@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

研究负责人通讯地址：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

Applicant address：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

Study leader's address：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Psychology, The Chinese University of Hong Kong

Applicant's institution：

Department of Psychology, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Psychology, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Psychology, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023.308

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-19 00:00:00

伦理委员会联系人：

Envy LEE

Contact Name of the ethic committee：

Envy LEE

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Nil

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Nil

Primary sponsor's address：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Nil

省(直辖市)：

Nil

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Nil

具体地址：

Nil

Institution
hospital：

The Chinese University of Hong Kong

Address：

Room 1302-04, Melbourne Plaza, Queen's Road Central, Hong Kong

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

Dementia Caregiver Stress  

Target disease：

Dementia Caregiver Stress

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To examine the locally adapted START dementia caregiver intervention and examine its clinical effectiveness in reducing depressive and anxiety symptoms and caregiver's stress  

Objectives of Study：

To examine the locally adapted START dementia caregiver intervention and examine its clinical effectiveness in reducing depressive and anxiety symptoms and caregiver's stress

药物成份或治疗方案详述：

The intervention programme consists of eight 1.5-2 hour sessions and will be delivered by clinical psychologist in group format. The programme included psychoeducation of dementia and caregiving stress, behavioral analysis and management skills, cognitive restructuring, communication skills, future planning, enhancing pleasant activities and relaxation techniques. Caregivers can continue home practice of skills with the manual and relaxation audios. 

Description for medicine or protocol of treatment in detail：

The intervention programme consists of eight 1.5-2 hour sessions and will be delivered by clinical psychologist in group format. The programme included psychoeducation of dementia and caregiving stress, behavioral analysis and management skills, cognitive restructuring, communication skills, future planning, enhancing pleasant activities and relaxation techniques. Caregivers can continue home practice of skills with the manual and relaxation audios. 

纳入标准：

The current study targets to recruit caregiver with dementia person in their family. The dementia person could be either taking care of the dementia person by the family or partially taking care by day care centre/other form of similar service in Hong Kong. The caregiver has to provide stable care towards the dementia person and regard themselves as a caregiver. Caregiver who lives with the dementia person or live separately could both be accepted. Caregivers are required to have basic literacy ability in Chinese to read the manuals and questionnaires. With reference to the previous research insight, we would recruit participants with a level of distress in caregiving in order to enhance the relevance of the therapy to the caregivers and to prevent the floor effect in the results. The short form of Zarit Burden Scale (Tang et al., 2016) would be used as a screening tool on the level of distress of the caregivers. With reference to the previous research on the scales (Yu et al., 2019; Bédard et al, 2001, & Tang et al., 2016), the cut-off score would be 19 or above.

Inclusion criteria

The current study targets to recruit caregiver with dementia person in their family. The dementia person could be either taking care of the dementia person by the family or partially taking care by day care centre/other form of similar service in Hong Kong. The caregiver has to provide stable care towards the dementia person and regard themselves as a caregiver. Caregiver who lives with the dementia person or live separately could both be accepted. Caregivers are required to have basic literacy ability in Chinese to read the manuals and questionnaires. With reference to the previous research insight, we would recruit participants with a level of distress in caregiving in order to enhance the relevance of the therapy to the caregivers and to prevent the floor effect in the results. The short form of Zarit Burden Scale (Tang et al., 2016) would be used as a screening tool on the level of distress of the caregivers. With reference to the previous research on the scales (Yu et al., 2019; Bédard et al, 2001, & Tang et al., 2016), the cut-off score would be 19 or above.

排除标准：

Due to the nature of the intervention programme, caregivers with dementia person staying in elderly home or having an active plan of letting the dementia person to be institutionalized will be excluded in the current study. Besides, caregivers with significant mental disorders e.g. schizophrenia or significant health conditions e.g. cancer, which affects their participation and application of the skills learnt in the programme, will also be excluded. Caregivers who are non-Chinese speaking or fail to read the manuals are not likely to be beneficial by the programme, hence they will not be recruited. Lastly, if the dementia person has significant difficulty to give any conscious response, the caregiver would be regarded as not suitable to be a participant of the study.

Exclusion criteria：

Due to the nature of the intervention programme, caregivers with dementia person staying in elderly home or having an active plan of letting the dementia person to be institutionalized will be excluded in the current study. Besides, caregivers with significant mental disorders e.g. schizophrenia or significant health conditions e.g. cancer, which affects their participation and application of the skills learnt in the programme, will also be excluded. Caregivers who are non-Chinese speaking or fail to read the manuals are not likely to be beneficial by the programme, hence they will not be recruited. Lastly, if the dementia person has significant difficulty to give any conscious response, the caregiver would be regarded as not suitable to be a participant of the study.

研究实施时间：

Study execute time：

从 From 2023-08-07 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-13 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：

Treatment Group

样本量：

 64

Group：

Treatment Group

Sample size：

干预措施：

START dementia caregiver intervention

干预措施代码：

Intervention：

START dementia caregiver intervention

Intervention code：

组别：

样本量：

 64

Group：

Control Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Treatment-as-usual

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Elderly Division, The Neightbourhood Action-Advice Council (NAAC) 

单位级别：

 N/A 

Institution
hospital：

Elderly Division, The Neightbourhood Action-Advice Council (NAAC)

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

醫院焦慮憂鬱量表

指标类型：

主要指标

Outcome：

Hospital anxiety and depression scale (HADS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Pretest and Posttest

Measure method：

Questionnaire

指标中文名：

廣東話短版沙氏負擔訪問

指标类型：

主要指标

Outcome：

Zarit Burden Interview Chinese short form (CZBI-Short)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Pretest and Posttest

Measure method：

Questionnaire

指标中文名：

簡明因應量表

指标类型：

次要指标

Outcome：

Brief COPE

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Pretest and Posttest

Measure method：

Questionnaire

指标中文名：

服務滿意程度量表

指标类型：

次要指标

Outcome：

Client Satisfaction Questionnaire (CSQ-8)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Posttest

Measure method：

Questionnaire

指标中文名：

腦精神科徵狀問卷

指标类型：

次要指标

Outcome：

Neuropsychiatric Inventory

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Pretest and Posttest

Measure method：

Questionnaire

指标中文名：

痴呆症臨床評估問卷

指标类型：

次要指标

Outcome：

Clinical Dementia Rating (caregiver parts)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Pretest and Posttest

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Nil

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Random Allocation Software (software for randomization) will be used by principal investigator for the randomization process. After recruiting the participants, they will be randomized into treatment and control group.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random Allocation Software (software for randomization) will be used by principal investigator for the randomization process. After recruiting the participants, they will be randomized into treatment and control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Nil

Blinding：

Nil

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

N/A

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-08-13 19:05:21